Clinical Research Associate, Sponsor Dedicated, IVD
About The Position
The Clinical Research Associate (CRA) designs, plans, coordinates, and conducts activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics. The role ensures that studies are conducted and documented in accordance with study protocols, standard operating procedures, good clinical practices, and applicable regulatory requirements. The CRA supports validation of product performance claims, supplies data for regulatory submissions, helps define the functional and clinical utility of investigational products, and obtains feedback on those products from laboratories, customers, and key opinion leaders. The role also maintains and continually improves the quality system and contributes to achieving quality objectives through daily work.
Requirements
- At least 2 years of experience as a Clinical Research Associate, including specific in vitro diagnostics study experience.
- Bachelor's degree in science or a relevant field.
- Excellent oral and written communication skills.
- Excellent planning, organizing, interpersonal, and leadership skills.
- Ability to work independently, make sound decisions, and analyze and solve problems.
- Demonstrated computer skills, including Microsoft Word, Excel, and basic templates.
Nice To Haves
- Clinical Research Associate certification from a recognized professional organization.
- Medical technology degree; not required if the candidate has an adequate R&D background.
Responsibilities
- Perform or coordinate clinical study activities, including site selection, study initiation, site monitoring, and study closeout.
- Maintain communication with study investigators to support timely study completion and achievement of study objectives.
- Interface with cross-functional staff to support post-launch activities.
- Review cases with investigators and resolve discrepancies.
- Understand and implement federal regulations.
- Help develop standard operating procedures to ensure studies adhere to FDA regulations, Good Clinical Practices, IVD directives, and client policies and procedures.
- Ensure studies are conducted and documented in accordance with protocols, standard operating procedures, good clinical practices, and applicable regulatory requirements.
- Validate product performance claims and supply data for regulatory submissions.
- Help define the functional and clinical utility of investigational products and obtain input on them from laboratories or customers.
Benefits
- Health and welfare benefits may be offered, depending on the position.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
